CureVac GmbH, the mRNA vaccine company, announced today first data from an open-label phase I/IIa clinical trial of its mRNA vaccine CV9103 in patients with hormone-refractory prostate cancer with rising PSA and existing metastasis in the vast majority of patients.
The trial was designed to assess safety and toxicity of CV9103 as well as its ability to induce antigen specific humoral and cellular immune responses in cancer patients. The results suggest that CV9103 is safe, well tolerated and biologically active. Over 70% of the study patients responded to at least one antigen out of the four antigens in CV9103. The trial evaluated a five dose regime of CV9103 delivered via intradermal injection in 44 patients.
The trial with CV9103, conducted in Germany and Italy, was the first to test a immunotherapy based on CureVac´s RNActive vaccination technology in humans. "CureVac's therapeutic mRNA vaccine induces responses against multiple antigens in 65% of immunologically responding patients when analyzing the data with strict criteria.
In addition, we see a response against all included antigens. These data are extremely encouraging," said Dr Kajo Kallen, CSO of CureVac. "The results are seen as a first important validation of CureVac's innovative proprietary RNActive® vaccination technology in humans."
The data generated from this first clinical application of CureVac´s RNActive vaccination technology provide the first clear evidence that CV9103 could represent a real step forward in the application of a new approach to the treatment of prostate cancer. This disease represents an area where there is an enormous unmet clinical need and this early success provides an active stimulus to expedite the development of this new technology.
Dr Ingmar Hoerr, CEO of CureVac, said: "These first results are excellent news for CureVac. We are highly motivated to further demonstrate the value of our RNActive vaccination technology in oncology and infectious diseases."
CureVac´s RNActive tumor immunotherapy approach is independent of the HLA subtype. The vaccine comprises mRNA molecules encoding four different antigens of which three are membrane bound. CV9103 is one candidate in CureVac's pipeline of RNActive-derived molecules for the active immunotherapy of cancer.
CureVac GmbH is a biopharmaceutical company specializing in the prophylactic and therapeutic application of messenger RNA (mRNA). CureVac's lead programme is dedicated to the development of active tumor immunotherapies, based on its RNActive technology. Furthermore CureVac develops prophylactic vaccines to protect from viral infections as well as adjuvants.
Currently, there are two candidates in clinical stage: CV9103 to treat prostate cancer, which in the US and Europe is the most common cancer and the second leading cause of cancer death in men. Additionally, CV9201, to treat non-small cell lung cancer (NSCLC). Lung cancer affects more than 1.4 million people worldwide and is the leading cause of cancer death.
Messenger ribonucleic acid (mRNA) is a genetic template for protein synthesis. It delivers the information encoded by genes from DNA to ribosomes where the information is translated into individual proteins. Natural RNA is an unstable biomolecule that is rapidly digested in the human body.
CureVac has proved it is possible to modify mRNA making it suitable for therapeutic purposes and maintaining its physiological properties. CureVac's RNActive-derived customized mRNA molecules are used to encode eg different tumour-associated antigens which are expressed by cells residing in the upper layers of the skin. Hence, the immune system recognizes these antigens on presentation to dendritic cells and react by forming both antigen-specific T-cells and humoral antibodies.
CureVac GmbH
